Statements (48)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory document
|
| gptkbp:address |
violations of FDA regulations
|
| gptkbp:appliesTo |
animal drugs
biologics dietary supplements cosmetics industry food industry medical device industry tobacco industry pharmaceutical industry veterinary products |
| gptkbp:common_violations |
adulteration
misbranding unapproved products |
| gptkbp:compatibleWith |
consent decree
seizure order import alert recall order |
| gptkbp:contentType |
contact information for FDA
description of violation required corrective actions timeline for response |
| gptkbp:effect |
not final agency action
|
| gptkbp:enforcement_discretion |
FDA may choose not to issue
|
| gptkbp:firstIssueDate |
1970s
|
| gptkbp:followedBy |
gptkb:seizure
injunction prosecution voluntary corrective action |
| gptkbp:frequency |
hundreds issued annually
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Warning Letters
|
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:legalBasis |
gptkb:Public_Health_Service_Act
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act gptkb:Tobacco_Control_Act |
| gptkbp:may_lead_to |
further enforcement action
|
| gptkbp:openToPublic |
yes
|
| gptkbp:publicInterest |
protect public health
promote compliance |
| gptkbp:publishedIn |
FDA website
|
| gptkbp:purpose |
notify regulated entities of violations
|
| gptkbp:recipient |
individuals
companies |
| gptkbp:response_required |
yes
|
| gptkbp:response_time |
usually 15 days
|
| gptkbp:usedIn |
enforcement actions
|
| gptkbp:bfsParent |
gptkb:US_Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
6
|